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Heart Failure and Hemodynamic Stability During Anesthesia Induction

NCT ID: NCT03576261

Last Updated: 2021-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2021-12-02

Brief Summary

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The study aim is to investigate whether preoperative heart failure has impact on hemodynamic stability during anesthesia induction by target controlled infusion of anesthesia (TCI) in non-cardiac, non-morbidly obese surgery.

Detailed Description

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40 individuals are enrolled to the study after signed informed consent at the day of surgery. The study participants are randomized (non-blinded) to preoperative fluid therapy (preoperative colloid fluid bolus at 6 ml/kg LBW, Gelofusine™, Fresenius Kabi AB, Sweden) or control (no preoperative fluids) before standardized TCI- induction of anesthesia. No other intravenous fluids before anesthesia induction.

Preoperative screening of biventricular systolic and diastolic function of the heart and level of venous return is implemented by transthoracic echocardiography approximately one hour before preoperative fluid therapy and anesthesia induction.

Conditions

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Hemodynamic Instability Anesthesia; Adverse Effect Heart Failure Diastolic Dysfunction Venous; Return (Anomaly)

Keywords

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hemodynamics venous return heart failure anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A consecutive cohort. Signed informed consent is gathered. Non-blinded randomization is conducted to fluid therapy before anesthesia induction. Preoperative diagnostics by echocardiography is conducted to all participants.Two arms, with or without preoperative fluids, are studied regarding hemodynamic stability during anesthesia induction.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Preoperative echo + fluids

20 individuals investigated by preoperative transthoracic echocardiography. Preoperative colloid fluid bolus (Gelofusine, Fresenius Kabi AB, Sweden) 6 ml/kg lean body weight, is infused intravenously immediately before anesthesia induction.

Group Type EXPERIMENTAL

Preoperative colloid fluid bolus (Gelofusine)

Intervention Type OTHER

Preoperative colloid fluid bolus

Preoperative transthoracic echocardiography

Intervention Type DIAGNOSTIC_TEST

Screening of biventricular systolic and diastolic function of the heart and level of venous return by transthoracic echocardiography approximately one hour before preoperative fluid therapy and anesthesia induction.

Preoperative echo, control

20 individuals investigated by preoperative transthoracic echocardiography. No intravenous fluids are infused before anesthesia induction.

Group Type ACTIVE_COMPARATOR

Preoperative transthoracic echocardiography

Intervention Type DIAGNOSTIC_TEST

Screening of biventricular systolic and diastolic function of the heart and level of venous return by transthoracic echocardiography approximately one hour before preoperative fluid therapy and anesthesia induction.

Interventions

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Preoperative colloid fluid bolus (Gelofusine)

Preoperative colloid fluid bolus

Intervention Type OTHER

Preoperative transthoracic echocardiography

Screening of biventricular systolic and diastolic function of the heart and level of venous return by transthoracic echocardiography approximately one hour before preoperative fluid therapy and anesthesia induction.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* age over 18 years
* body mass index ≤ 35 kg/m2
* electively scheduled for breast cancer surgery, endocrinologic surgery (thyroid, parathyroid) and general abdominal surgery

Exclusion Criteria

* instable angina pectoris
* severe bronchial asthma
* severe COPD
* dementia
* severe heart valve disease
* severe renal failure
* body mass index \> 35 kg/m2
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Umeå University

OTHER

Sponsor Role lead

Responsible Party

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Tomi Myrberg

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tomi Myrberg, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Umea Universitet

Locations

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Sunderby teaching hospital

Luleå, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2016/361-31 III

Identifier Type: -

Identifier Source: org_study_id